2014 State Medical Device Development Report

State of
Medical
Device
Development
2014
2014 State of Medical Device Development | seapine.com
Executive Summary
The demand for smarter, safer, more connected
medical devices has introduced new complexities
to the development process. As medical device
manufacturers race to bring innovative new
products to market, they must overcome the
challenges these complexities createmanaging
product risk, documenting proof of compliance
with industry regulations, and streamlining
development with new methods and tools.
To help manage these challenges, medical
device companies have found new ways to
improve the product development process.
These process improvementsand the
challenges that drive themare what we
sought to understand with the 2014 State
of Medical Device Development Survey.
Managing risk is the first key challenge survey
respondents identified. In order to be effective,
risk mitigation artifacts must be visible to
everyone involved in the development
and testing of the product. Teams have found that

storing risk documentation on a shared drive or in a
document control system often results in key team
members seeing it too late in the process. This causes
expensive rework that could have been avoided if the
risk artifacts were more visible.
Working with documents is the second key challenge
identified by respondents. Teams are losing valuable
time as they struggle to manually manage the reports,
matrices, and other documentation needed to
facilitate development and provide proof of regulatory
compliance. This time could be better spent refining
the product and getting it to market faster, but
outdated tools have most teams hobbled with manual
documentation.
Key Challenges
The 2014 State of Medical Device
Development Survey identified three
overall challenge areas:
1. Managing Risk: Teams struggle to
make risk more visible across the
development lifecycle.
2. Working with Documents: Teams spend
far too much time managing, linking,
and reviewing documents.
3. Overcoming Barriers to Improvement:
Budget, validation overhead, and
bureaucracy prevent companies from
making needed improvements.
It should be no surprise, then, that the final key

challenge identified is overcoming barriers to
improvement. Despite a clear need to get better
development lifecycle management solutions in place,
companies are restricted by tight budgets, validation
overhead, and bureaucracy.
About the Survey

The 2014 State of Medical Device Development Survey was conducted from June 1,
2014 through August 31, 2014 and sponsored by Seapine Software. We gathered
input from almost 500 individuals working at all levels within the medical device
industry. The majority of respondents were working on Class II or Class III devices,
with a smaller number also involved in the development of Class I devices.
Altitude: The survey respondents represent all levels within medical device
development companies.
Senior Executive
What is
your current
level within the
organization?
36%
Professionals
35%
Management
29%
Experience: Although all levels of experience in the industry were

represented, this years survey attracted more experienced practitioners.
Less Than
5 Years
21%
How
long have
you been
working in the
life sciences
Industry?
10+ Years
61%
5-10 Years
18%
Role: Respondents were concentrated in the engineering and quality groups,

with additional input from the research side.
Other
2%
What is
your current
role within the
organization?
Research
9%
Regulatory &
Quality
32%
Engineering
57%
Key Challenge: Managing Risk

Ensuring that risk analysis and mitigation work is
incorporated into the final device is important
to making certain a device is safe to use. This
years survey shows that more teams are using
document control systems (EDCM, QMS, etc.) instead
of storing their risk management documents in a
shared network. The motivation for this move is often
compliance-related (ISO 14971, IEC 62304, etc.) or
because the team needs to make risk more visible.
Unfortunately, visibility into risk is still limited in
a document control system. To comply with
increasingly stringent regulatory requirements,
leading companies are implementing next
generation techniques and tools to improve
risk visibility. These purpose-built solutions
enable teams to conduct risk analysis and
mitigation within a comprehensive,
Documents
end-to-end, wholly traceable system,
Under
Document
capturing and recording all relevant
Control
43%
data throughout development.
How
do you
manage risk
identification,
analysis, and
mitigation?
Broken Down into Individual Risk

Artifacts in a Commercial Software Tool
10%
Documents
on Shared
Network
47%
Methods Used
The top three methods used for mitigating risk in this years survey were Failure
Mode Effects Analysis (FMEA), risk management files, and Root Cause Analysis
(RCA). Nearly 70% of respondents said they also use Corrective and Preventative
Action (CAPA) as part of their quality management system. No distinction was made
between reactive and proactive methods.
FMEA
Risk Management
Files
RCA
What
types of risk
management
methods do
you use?
FTA
PHA
FMECA
Nothing Formal
HACCP
RCCA
HAZOP
Safety Assurance
Cases
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Tracking Risk
Survey results show two-thirds of teams start tracking risk before device
development work is started. This helps teams avoid costly rework by identifying
potential risks early in the development process. The danger is that all of that risk
information can get lost or forgotten once the actual development work begins, if
its locked away in a document control system.
When
do you start
documenting
risk?
31%
Phase
0%
10%
Concept
20%
35%
30%
40%
Feasibility
50%
60%
27% 7%
70%
Development
80%
90%
100%
Verication
Increasing Visibility
Tracking risk alongside design and testing assets
in an integrated product development solution
not only keeps risk visible to the team throughout
development, it also improves visibility into risk
assessment and mitigation efforts across the entire
organization. This heightened visibility helps ensure
risk management work done early in the process is
not lost or forgotten once development begins.
New regulatory requirements and an increased
focus on the cost of care are challenging device
manufacturers to improve visibility across the
development lifecycle in order to meet aggressive
deadlines and prove a devices safety and efficacy.
We asked respondents to identify the top 3 areas
where they need improved visibility.
10
Top 3 Elements Needed for a Successful Project

The top 3 here are critical for a successful project:
1. Project status keeps the projects key requirements visible, helping teams meet
deadlines and stay within budget.
2. Effective impact analysis of proposed changes ensures changes do not derail the
project schedule. This is almost impossible to do with a document-centric approach.
3. Risk controls ensure the product is safe to use and are also an important component
of regulatory approval.
Project Status
What
are the top
three pieces
of information
you wish you had
better visibility
into?
Impact
Analysis
Risk Controls
Gap Analysis
Related
Requirements
User Needs
Related Defects
Change
Management
Trace
Structure
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
11
Key Challenge: Working with Documents

Getting new devices to market depends on proving regulatory compliance, and
that depends on having the proper documentation. For the third year in a row,
documenting work and reviewing that documentation are cited as the top two timeconsuming aspects of the product development process.
Documenting
Work
Reviewing
Documentation
Communication
& Collaboration
What
are your
most timeconsuming
tasks?
Organizing
Work
Data
Analysis
Prioritizing
Work
Objective
Evidence
Researching
Related Items
Seeking
Approvals
Linking Related
Items
Updating Multiple
Systems
Establishing
Risk Controls
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12
Because of the challenges involved in developing

todays devices, many companies have adopted
product development software solutions that
automate the creation and maintenance of the
necessary traceability documentation. These
solutions are often part of a comprehensive,
end-to-end system that captures and records
all relevant data, from design to development to
service and support.
By adopting these purpose-built solutions,
companies can increase team productivity and
product quality while mitigating risk and proving
regulatory compliance. These solutions track the
individual artifacts created during the development
process, giving teams better visibility and control
than a document-centric solution can offer.
13
Between 2011 and 2013, we saw a large jump in the number of companies adopting
these solutions to help them better manage their product development. This
years results show the adoption of product development software solutions has
stagnated a bit.
Use
of artifactcentric vs.
documentcentric
approach
2014
2013
2011
0%
10%
20%
30%
40%
Artifact-Centric
50%
60%
70%
80%
90%
100%
Document-Centric
14
The reason for this slowdown isnt clear, but when we analyzed it demographically,
we noticed a higher adoption rate among respondents who are newer to the
industry. It could be that professionals with more experience are accustomed
to the way weve always done it and are hesitant to change, or that newer
professionals have more knowledge about the latest technologies and methods
being practiced with success in other industries.
100
The use
of documentcentric tools is
high among more
experienced
professionals
75
50
25
1-5 Years Experience
5-10 Years Experience

Document-Centric
10+ Years Experience
Artifact-Centric
15
DOCUMENT-CENTRIC VS. ARTIFACT-CENTRIC

A document-centric approach is any approach
An artifact-centric approach focuses on working
based on managing large documents in their entirety.
with individual project assets or artifacts. These
Document-centric approaches limit reusability,
artifacts can be sent out for review to only the people
traceability, visibility, and team-based work. These
responsible for each piece, with a commercial tool
documents are usually worked on as a single unit,
centralizing their changes. Theres no need to merge
rather than breaking out each artifact into its own
changes because user A will see user Bs change in
document. To avoid a substantial amount of manual
real time and can adjust their updates and feedback
merging and potential error, only one person can
accordingly. Artifact-centric approaches allow for
update the document at a timelengthening review
much better data, risk, gap, and impact analyses,
cycles and requiring traceability to be managed
and reviewed artifacts can still be compiled into a
separately. Ultimately, it becomes increasingly
final document. With commercial software tools
difficult to manage, transfer, and reuse key data as
assisting in artifact management, users can focus on
portions of documents evolve into other work or
tasks instead of constantly maintaining documents.
artifacts.
An artifact-centric approach can also easily support

various development methodologiesspiral,
iterative, parallel, Agile, and other alternatives to
Waterfall methods.
16
Managing Requirements
When a product development effort reaches design control, the need increases to
move from working in Excel and Word to a more specialized solution. This years
survey results show teams continuing to move into specialized commercial tools to
manage the creation, review, and implementation of product requirements during
design control.
When you factor in the complexity of todays products and the number of teams
required to bring a product to market, its not surprising that more are choosing to
move away from documents and into commercial tools built specifically to manage
the product development lifecycle.
Other
8%
How do
you manage
requirements?
Commercial
Tool
20%
Documents
on Shared
Network
40%
Documents
Under
Document
Control
32%
17
Verifying Change
In 2011, only 32% of respondents were using electronic signatures in their approval
and audit processes. Last year, that number grew to 40%, and this year e-signature
usage equals the use of manual signatures to verify requirements changes.
We expect this trend to continue as more regulatory teams embrace electronic
signatures and adopt tools to support this functionality.
How
do you
verify approved
or changed
requirements?
50%
2014
50%
40%
2013
60%
32%
2011
0%
10%
20%
30%
68%
40%
50%
Electronic Signatures
60%
70%
80%
90%
100%
Manual Signatures
18
Managing Quality and Testing

Although document control is still more common for managing risk and design
artifacts, respondents have broadly adopted commercial tools for managing testing.
The industry appears near the tipping point, where commercial solutions will soon
become the most common method for managing the testing effort.
Do Not Manage
Test Cases
8%
How do you
manage your
testing efforts?
Completely
Electronic
(Software
designed to
manage test
cases)
Manual
(Printed documents)
20%
25%
Electronic
(Static
documents in a
document or
quality control
system)
Somewhat
Electronic
(Word or Excel
documents
managed in
directories)
26%
21%
19
As with requirement changes, more teams are taking advantage of technology to

electronically sign test cases and results. We expect this trend to continue as tool
adoption increases.
How do you
verify completed
test cases?
39%
2014
61%
35%
2013
0%
10%
20%
30%
65%
40%
50%
Electronic Signatures
60%
70%
80%
90%
100%
Manual Signatures
20
Improving Traceability
Traceability not only connects the entire product development process, but also is
key to gaining regulatory approval for medical devices. Teams using a documentcentric approach spend an inordinate amount of time digging through documents
to ensure accurate traceability from design through code and testing. Teams are
slowly finding ways to reduce the time spent on traceability, but almost half still
waste a days effort or more each time they need to update the trace matrix.
100
How
long does
it take to update
the traceability
matrix?
75
50
25
Minutes
Hours
2011
Days
2013
Weeks
Dont Know
2014
21
This isnt too surprising

when you consider the
number of artifacts and
work items involved
especially when all of
these different assets
are buried in documents
scattered across the
company.
What
development
artifacts are
included in your
traceability
matrix?
Product
Reqs
User
Reqs
Test
Cases
Risk
Artifacts
System
Specs
Test
Runs
Marketing
Reqs
Defects
Development
Tasks
Feature
Requests
User Stories
Code
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
22
Adding to the problem is the fact that more teams are creating the trace matrix
early, so it will be more complete and accurate. These teams are likely balancing
that benefit with the reality that creating the trace matrix early also means much
more time spent updating it.
At what
point in the
project is the
traceability
matrix
created?
19%
Phase
0%
10%
43%
20%
30%
During Concept/Feasibility
40%
50%
Start of Design
60%
25%
70%
80%
Start of Verication
13%
90%
100%
Right Before
23
Key Challenge: Overcoming Barriers to Improvement

Maintaining an effective development processone that fosters innovation while at
the same time ensuring full regulatory compliancerequires a delicate balance of
culture, methodology, and technology.
When asked to identify the top three hurdles they faced in trying to improve their
development processes, respondents chose budget, validation overhead, and
bureaucracy.
Budget
What are
the top three
issues that prevent
you from improving
your product
development
processes?
Validation
Overhead
Bureaucracy
Consensus
Decision
Integrating Existing
Tech Investments
Lack of Good
Existing Processes
Interpreting
Regulatory
Guidelines
Lack of
Tools
No Support
From IT
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
24
Budget
Budget is once again the top issue that organizations perceive to be preventing
them from improving their product development processes. This should come as no
surprise, given the economic issues that continue to challenge the industry. Teams
struggle under increasing pressure to reduce costs and get products to market
faster, yet they may get pushback from upper management when they request
new tools that will help them meet these demands. Fewer companies embrace the
spend money to make money philosophy, leaving their teams handicapped with
outdated development tools.
Validation Overhead
Its interesting to note that the cost and time spent validating new and upgraded
systems jumped to second on the list in this years results. Only 27% reported it
as a top barrier to preventing improvement last year. This year, nearly half say it is
keeping them from improving their product development processes.
Bureaucracy
Managers were the only respondents for whom bureaucracy remained the second
biggest barrier to improvement, but it was still high on the list for non-management
respondents. Its clear that companies need to simplify the complicated rules and
processes that stand in the way of improvements their development processes.
25
Agiles Place in Medical Device Development

In January 2013, FDA officially acknowledged Agile by adding AAMI TIR45:2012, Guidance on
the Use of Agile Practices in the Development of Medical Device Software to its list of
recognized standards. To gauge Agiles popularity in the industry, we asked respondents if
they were using Agile or some hybrid methodology that incorporates Agile concepts.
Almost half of the respondents said they are either successfully using Agile or hybrid
methods or are planning to adopt them within the next 12 months. Another third
of respondents are working to understand how or if Agile practices can help their
development efforts.
Are you
using Agile
or some hybrid
methodology?
Planning To
Adopt Agile Or
Hybrid Practices
In The Next
12 Months
28%
Successfully
Using Agile
Or Hybrid
Practices
20%
Working to
Understand
How Agile Fits
with Regulatory
Requirements
30%
Dont Believe
Agile Fits With
Regulatory
Requirements
22%
Electroni
(Stati
document
management in
a document o
quality contro
system
21%
26
Among Seapines medical device customers, we most often see a

hybrid approach. The software teams tend to incorporate some
Agile practices into their processes to iterate fast and respond to
change, while retaining all of the traceability and documentation
required to get a product through regulatory approvals. In many
cases its a more process-heavy version of Agile than is typical in
other industries.
The Path Forward: Collaboration, Visibility, Traceability

New regulatory requirements and an increased focus on the cost
of care are challenging device manufacturers to improve visibility
into the entire development lifecycle in order to meet aggressive
deadlines and prove a devices safety and efficacy.
Regulatory compliance is key to driving new products to market,
and the keys to compliance are managing risk and providing the
documentation to back it up. Because of the challenges involved
in regulatory documentation, generating the required traceability
documents should be an automated process. Companies should
look to a purpose-built software solution that incorporates this
functionalitypreferably one that conforms to their business
needs and processes.
27
The solution needs to be more than a document

control system, however. It should be part of an
integrated system that increases visibility of all
development artifacts, particularly those related to
risk. The right software solutions can help support
better methods and practices, improve team
collaboration, and remove much of the administrative
burden associated with regulatory compliance.
28
About Seapine Software

With over 8,500 customers worldwide, Seapine Software, Inc., is the
leading provider of quality-centric product development solutions.
Headquartered in Cincinnati, Ohio, with offices in Europe, Asia-Pacific,
and Africa, Seapines development solutions help organizations ensure
the consistent release of high quality products, while providing
traceability, metrics and reporting, and compliance.
Learn more at seapine.com.

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State of

and testing of the product. Teams have found that

It should be no surprise, then, that the final key

About the Survey

2014 State of Medical Device Development | seapine.com

Experience: Although all levels of experience in the industry were

2014 State of Medical Device Development | seapine.com

Role: Respondents were concentrated in the engineering and quality groups,

2014 State of Medical Device Development | seapine.com

Key Challenge: Managing Risk

Broken Down into Individual Risk

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com

Top 3 Elements Needed for a Successful Project

2014 State of Medical Device Development | seapine.com

Key Challenge: Working with Documents

2014 State of Medical Device Development | seapine.com

Because of the challenges involved in developing

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com

1-5 Years Experience

5-10 Years Experience

10+ Years Experience

2014 State of Medical Device Development | seapine.com

DOCUMENT-CENTRIC VS. ARTIFACT-CENTRIC

An artifact-centric approach focuses on working

based on managing large documents in their entirety.

with individual project assets or artifacts. These

Document-centric approaches limit reusability,

artifacts can be sent out for review to only the people

traceability, visibility, and team-based work. These

responsible for each piece, with a commercial tool

documents are usually worked on as a single unit,

centralizing their changes. Theres no need to merge

rather than breaking out each artifact into its own

changes because user A will see user Bs change in

document. To avoid a substantial amount of manual

real time and can adjust their updates and feedback

merging and potential error, only one person can

accordingly. Artifact-centric approaches allow for

update the document at a timelengthening review

much better data, risk, gap, and impact analyses,

cycles and requiring traceability to be managed

and reviewed artifacts can still be compiled into a

separately. Ultimately, it becomes increasingly

final document. With commercial software tools

difficult to manage, transfer, and reuse key data as

assisting in artifact management, users can focus on

portions of documents evolve into other work or

tasks instead of constantly maintaining documents.

An artifact-centric approach can also easily support

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com

Managing Quality and Testing

2014 State of Medical Device Development | seapine.com

As with requirement changes, more teams are taking advantage of technology to

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com

This isnt too surprising

2014 State of Medical Device Development | seapine.com

2014 State of Medical Device Development | seapine.com